New LDL-lowering therapy safe, effective in phase 2b trial

Esperion Therapeutics announced favorable top-line results from a phase 2b study assessing the safety and efficacy of a treatment for patients with hypercholesterolemia.

The once-daily, orally administered therapy is primarily intended for use instatin-intolerant patients, according to a press release.

The double blind, parallel-group, multicenter ETC-1002-008 study evaluated monotherapy with ETC-1002 vs. ezetimibe among patients with hypercholesterolemia, with or without intolerance to statins. Patients were randomly assigned to receive one of the following regimens for 12 weeks: 120 mg (n=99) or 180 mg (n=100) of ETC-1002 alone; 10 mg ezetimibe alone (n=99); or 10 mg ezetimibe in addition to 120 mg (n=26) or 180 mg (n=24) of ETC-1002, according to the release. The primary endpoint of the trial was reduction in LDL from baseline.  

LDL was reduced by 27% in the 120 mg and 30% in the 180 mg ETC-1002 monotherapy groups, compared with 21% in the ezetimibe monotherapy group (P=.0008 for 120 mg and P<.0001 for 180 mg vs. ezetimibe). Significantly greater reductions in LDL were also observed in the groups that received combination therapy, with a 43% reduction in the 120 mg group and 48% in the 180 mg group (P<.0001 for both comparisons with ezetimibe monotherapy), according to the release.

The researchers also observed a significantly greater reduction in high-sensitivity C-reactive protein among patients who received ETC-1002 rather than ezetimibe monotherapy.

Patients discontinued treatment due to adverse events at similar rates between ETC-1002 and ezetimibe recipients, according to the release. Rates of events and serious events were low, and similar between the groups.

“Many people with hypercholesterolemia are not able to control their LDL cholesterol levels with currently available therapies,” Paul Thompson, MD, medical director of cardiology and the Athletes’ Heart Program at Hartford Hospital, said in the release. “ETC-1002 has the LDL cholesterol-lowering [ability] of a mid-dose statin and is well-tolerated, and could benefit these patients.”

Source: www.healio.com